| CTRI Number |
CTRI/2022/10/046550 [Registered on: 17/10/2022] Trial Registered Prospectively |
| Last Modified On: |
10/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of Ashwagandha extract in people with disturbed sleep |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Ashwagandha (Withania somnifera)
Extract in the management of Insomnia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-01SLP0622H6-WES11, Version 1 dated 4 July 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giby Abraham |
| Designation |
Research Associate |
| Affiliation |
Arjuna Natural Pvt. Ltd |
| Address |
Innovation Center,
Door No. 187 D, Behind ISRO,
Erumathala P.O, Keezhamd
Ernakulam
KERALA
683112
India |
| Phone |
09288004381 |
| Fax |
|
| Email |
giby.a@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Private Limited, Aluva, Kerala |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Private Limited, |
| Address |
Bank Road, Aluva,
Kerala, India - 683 101 |
| Type of Sponsor |
Other [Neutraceutical company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deo Nidhi Mishra |
Nirmal Hospital |
Department of Internal Medicine,
Opp. MLB Medical College,
Gate No:3, Kanpur Road, Jhansi-284128
Jhansi
UTTAR PRADESH |
09415031689
drmishra.nirmal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nirmal Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
sleep |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha extract |
500 mg once daily for 30 days |
| Comparator Agent |
Placebo |
500 mg once daily for 30 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
1. A primary complaint of sleep-onset insomnia for at least 6 months defined as a sleep-onset latency of at least 1 hour over 3 nights a week as verified by pre-screening sleep diaries
2. At least 1 negative daytime complaint (eg, fatigue, impaired mood, or performance) attributed to insomnia
3. Pittsburgh Sleep Quality Index (PSQI) Score > 5
4. Insomnia Severity Index (ISI) Score 15 – 21
5. Athens Insomnia scale score >10
6. STOP-BANG score < 3
7. Sleep Onset Latency >31 minutes a night, as confirmed by the pre-screening sleep diary
8. Willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. Current use of prescription or over-the-counter sleep medications or unwillingness or inability to discontinue use of these medications at least 4 weeks before beginning the study
2. Medical problems that would be a direct cause of insomnia
3. Current treatment for depression, alcohol or substance abuse, or psychosis
4. Previous diagnosis of sleep apnea or periodic limb movements or prior CBT for insomnia
5. Initiation of psychotherapy in the previous 6 months
6. Women of childbearing age who were pregnant, breastfeeding, or not practicing contraception
7. Shift work
8. Epworth Sleepiness Scale (ESS) a score ≥ 9
9. Beck depression inventory-II(BDI-II) > 13
10. Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Sleep questionnaires |
Baseline, Day 15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Sleep diary |
Baseline to Day 30 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
19/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, double-blind, placebo-controlled study in participants with disturbed sleep. Qualified participants will be randomized into two groups in 1:1 ratio to test product or placebo and advised to take 500 mg of capsule for 30 days. The participants were assessed by sleep questionnaires and sleep diary.
|